Canadian clinical trial registry

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Study Description

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria

• Patients must be less than or equal to 25 years of age at the time of enrollment
• Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
• Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
• Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
• Patients must have adequate performance status (daily activities which they are able to do) 
• Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
• Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
• Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This phase 2 trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT-driven medulloblastoma.

(via: https://childrensoncologygroup.org/acns1422)

Inclusion Criteria

• Patients are between 3 years to 21 years old
• Patient is newly diagnosed with average-risk medulloblastoma  in the WNT subgroup by institutional diagnosis
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a phase II study to treat patients with neuroblastoma that has come back (relapsed) or is not responding to previous treatment (refractory). This study is seeing if combining eflornithine (a drug used to block the production of chemicals that may cause growth of cancer cells) with drugs used in chemotherapy/immunotherapy (irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab) may work better in treating patients with relapsed or refractory neuroblastoma compared to using irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab alone. Patients will be randomly assigned to 1 of 2 regimens, one regimen will recieve eflornithine with the chemotherapy/immunotherapy drugs and the other regimen will recieve chemotherapy/immunotherapy drugs without eflornithine.

Inclusion Criteria

• Patients must have a neuroblastoma that has come back, progressed or not responded to previous treatment
• Patients must be 1 year of age or older
• Patients must be up and about at least 50% of their waking hours
• 14 days must have passed if patients have recieved any treatment that supresses bone marrow
• >= 21 days must have passed from infusion of antibodies
• Patients must not have received radiation for a minimum of 4 weeks before joining the study. Palliative radiation while on study is not permitted.
• Blood work must come back within the acceptable ranges
• Patients must have no evidence of shortness of breath, and no need for supportive oxygen 
• Patients with a history of central nervous system (CNS) disease must have no evidence of active CNS disease at the time of study enrollment
• Patients with seizure disorders may be enrolled if seizures are well controlled on proper medication
• Patients of childbearing potential must have a negative pregnancy test to be eligible for this study and must agree to use adequate contraception while enrolled on this study.

Other inclusion and exclusion criteria may apply and will be reviewed by your treating team.

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Study Description

This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a suspected or confirmed diagnosis of DIPG or newly diagnosed high-grade glioma (HGG) that hasn’t spread.
3. Consent: A parent or guardian, or the patient, must sign a consent form.
4. Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).

Main Enrollment

1. Age: Patients must be between 1 and 21 years old.
2. Diagnosis:
   • DIPG: Must meet specific imaging or biopsy criteria.
   • HGG: Must be newly diagnosed, without certain genetic mutations.
3. Patients need to be in good overall health with normal lab results and no severe symptoms.
4. Enrollment must happen within 31 days of diagnosis or surgery.
5. A signed consent form is required.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria

• Children 1 month to 21 years of age
• Acute myeloid leukemia that has come back or is not responding to current treatment
• Presence of the FLT3-ITD mutation in the leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria

• Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
• Body weight ≥ 10 kg
• A new diagnosis of diffuse glioma with a H3 K27M mutation 
• Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
• Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

 This study is eligible for STEP-1 funding. Find more information here. 

 This study is eligible for STEP-1 funding. Find more information here. 

This study is testing a medicine called nivolumab for people with a type of brain cancer called RRD-glioblastoma. The goal is to see if this medicine can help delay or avoid the need for radiation treatment.

Inclusion Criteria

• Patient must be between 1 and 25 years old.
• Must have glioblastoma, confirmed by a biopsy
• Tumor must show certain genetic changes linked to RRD, confirmed by tests on the tumour
• A sample of the tumor is needed for analysis, and another sample may be required if the tumor grows back
• Most or all of the tumor must have been removed in surgery, and treatment should start within 4 weeks after surgery.
• No treatments (like chemotherapy or radiation) for glioblastoma are allowed before the study, but surgery is okay. Past treatment for other cancers is allowed if previous cancer is in remission
• Must have good overall health, including healthy organs and no serious infections
• Participants and their families must agree to join the study

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.